CN108025156B

CN108025156B - Breathing assembly

Info

Publication number: CN108025156B
Application number: CN201680055181.5A
Authority: CN
Inventors: 斯图尔特·希瑟林顿; 哈恩·彼得斯切基; 迈克尔·斯图德旺
Original assignee: Snap CPAP LLC
Current assignee: Snap CPAP LLC
Priority date: 2015-10-06
Filing date: 2016-10-06
Publication date: 2021-01-15
Anticipated expiration: 2036-10-06
Also published as: CA2999190A1; MX2018004168A; AU2016334080B2; BR112018007048B1; AU2016334080A1; WO2017062677A1; BR112018007048A2; JP2018530389A; KR20180056776A; CN108025156A; CA2999190C; JP7040773B2

Abstract

The present invention provides a respiratory assembly that includes a base engaged with at least one connector and in fluid communication with a hose or fluid source to allow for the communication of gases between the at least one connector, the base, and the hose or fluid source. The assembly further includes a pair of sleeves engaged with the at least one connector and a pair of posts, each post selectively engaged with at least one sleeve of the pair of sleeves, wherein each post includes a flange defining an opening therethrough in fluid communication with each corresponding sleeve of the pair of sleeves; each post also includes an adhesive adhered to each flange and configured to sealingly engage the patient's nares.

Description

Breathing assembly

Cross Reference to Related Applications

This application is, in part, a continuation of U.S. patent application 14/876009 filed on day 6/10/2015, U.S. patent application 26/916445 filed on day 13/9/2016, U.S. patent application 26/916453 filed on day 13/9/2016, U.S. patent application 26/916474 filed on day 13/9/2016, and provisional patent application 62/495576 filed on day 13/9/2016, the contents of which are hereby incorporated by reference in their entireties.

This application is related to U.S. patent application 13/672946 filed on 9/11/2012 and is published as U.S. patent 9,149,595, which claims priority to U.S. provisional patent application 61/562056 filed on 21/11/2011, which has now expired and the contents of which are hereby incorporated by reference in their entirety.

Technical Field

The present disclosure relates to respiratory assemblies and, more particularly, to respiratory assemblies having nostril engaging portions for providing sealable engagement of treatment fluids.

Background

Continuous positive pressure ventilation masks are used to treat patients suffering from any sleep or breathing disorder during sleep. CPAP masks may deliver a treatment fluid, such as ambient air or oxygen-enriched air, to a patient at a predetermined or desired pressure setting.

CPAP masks have a number of drawbacks, for example, they are bulky, making them aesthetically and ergonomically unsatisfactory. The CPAP mask must be in sealing engagement with the patient's skin in order to maintain a sealed environment to achieve the pressure required for treatment fluid delivery. This sealed engagement leaves a wear mark on the patient's skin, and it may take a long time for the wear mark to disappear. Therefore, many patients feel uncomfortable in public places before the wear marks disappear, and male patients may not shave faces and female patients may not apply cosmetics before the wear marks disappear. These depressions or marks may be caused by masks that wrap around the mouth and/or nostrils and straps or connectors that may be positioned around the patient's head.

Due to the bulky nature of conventional CPAP masks, the mask occupies a significant portion of the face of a person. This limits the person's head from moving during sleep, as lying on the side of the person's face may contact the CPAP mask and disengage the mask from the patient's sealing engagement, thereby venting pressure in the mask assembly. This is undesirable because the patient is not receiving therapeutic gas at the desired pressure or the patient is awakened.

Accordingly, there is a need for an improved CPAP breathing assembly that addresses the disadvantages associated with conventional CPAP machines and masks. Additionally, there is a need for a strapless and facemask-less CPAP breathing assembly, thereby addressing the bulky and impression-forming characteristics of conventional CPAP machines and masks.

Disclosure of Invention

This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

According to at least one embodiment, a respiratory assembly is provided. The breathing assembly includes a base engaged with the at least one connector and the hose or fluid source to allow gas communication between the at least one connector and the hose or fluid source; a pair of sleeves engaged with the at least one connector; a pair of posts, each post selectively engageable with at least one of the pair of sleeves, wherein each post comprises: a flange defining an opening therein in gaseous communication with each corresponding sleeve of the pair of sleeves; an adhesive is applied to each flange and is configured to sealingly engage the patient's nares.

According to at least one embodiment, a respiratory assembly is provided. The breathing assembly includes: a base engaged with the at least one connector and the hose or fluid source for allowing gas communication between the at least one connector and the hose or fluid source; a pair of sleeves engaged with the at least one connector; a pair of cleat assemblies, each cleat assembly selectively engageable with at least one of the pair of sleeves, wherein each cleat assembly defines: a splint flange engaged with the sheet comprising adhesive for engaging the patient's nares; a clamp plate opening in gaseous communication with each corresponding sleeve of the pair of sleeves; at least one clip ridge for selectively engaging at least one sleeve ridge of one of the pair of sleeves.

Drawings

The foregoing summary, as well as the following detailed description of preferred embodiments, is better understood when read in conjunction with the appended drawings. For the purpose of illustration, there are shown in the drawings exemplary embodiments; however, the presently disclosed invention is not limited to the specific methods and instrumentalities disclosed. In the drawings:

FIG. 1 shows a schematic view of a respiratory mask and a patient to be treated in accordance with one or more embodiments disclosed herein;

FIG. 2 shows a schematic view of a mask according to one or more embodiments disclosed herein;

FIG. 3 shows a schematic view of a nasal assembly and a patient to be treated in accordance with one or more embodiments disclosed herein;

FIG. 4 illustrates a schematic view of a portion of a nasal assembly according to one or more embodiments disclosed herein;

FIGS. 5A and 5B illustrate respective perspective and side views of a nasal assembly for use with a respiratory mask according to one or more embodiments disclosed herein;

fig. 6 illustrates a perspective view of a respiratory assembly having a base and a single connector in accordance with one or more embodiments disclosed herein;

fig. 7 illustrates a rear view of a respiratory assembly having a base and two connectors in accordance with one or more embodiments disclosed herein;

fig. 8 illustrates a schematic view of a base of a respiratory assembly having two openings in accordance with one or more embodiments disclosed herein;

fig. 9 illustrates a bottom view of a base of a respiratory assembly having two base openings in accordance with one or more embodiments disclosed herein;

fig. 10 illustrates a rear view of a base of a respiratory assembly having two base openings in accordance with one or more embodiments disclosed herein;

fig. 11 illustrates a rear view of a base of a respiratory assembly having four base openings and two caps in accordance with one or more embodiments disclosed herein;

FIG. 12 illustrates a cleat assembly and a rotatable sleeve assembly in accordance with one or more embodiments disclosed herein;

13A-13D illustrate schematic views of a sleeve assembly and a cylinder in accordance with one or more embodiments disclosed herein;

FIG. 14A illustrates a schematic view of a sleeve assembly with a clamp lock in accordance with one or more embodiments disclosed herein;

FIG. 14B illustrates a top view of a sleeve assembly with a clamp lock according to one or more embodiments disclosed herein;

FIG. 14C illustrates a side view of a sleeve assembly with a clamp lock according to one or more embodiments disclosed herein;

fig. 14D illustrates a bottom view of a sleeve assembly with a clamp lock in accordance with one or more embodiments disclosed herein.

Detailed Description

The presently disclosed invention is described with specificity to meet statutory requirements. However, the description itself is not intended to limit the scope of this patent. Rather, the inventors have contemplated that the claimed invention might also be embodied in other ways, to include different steps or elements similar to the ones described in this document, in conjunction with other present or future technologies.

Fig. 1 illustrates a respiratory assembly mounted on a patient 1 according to at least one embodiment. Such an embodiment has been described in detail in U.S. patent application 13/672,946, filed on 9/11/2012 and is disclosed as U.S. patent 9,149,595. The respiratory assembly is generally designated 10 throughout the drawings. The assembly 10 includes a nasal assembly 12. Nasal assembly 12 may include at least one post 14 having a nose engaging portion 16, the nose engaging portion 16 being located at or near a first end thereof for delivering therapeutic gas to the nasal cavity of patient 1. The post 14 may be configured to provide a flush, sealable engagement with the patient's nares.

The respiratory assembly 10 may include a mask assembly 20 having an inlet 22 for receiving therapeutic gas from a fluid source 41 and at least one receptacle 24 for sealing engagement with the column 14. The fluid source 41 may be a Continuous Positive Airway Pressure (CPAP) machine, a fluid tank, a humidifier, or other fluid source. The post 14 may be selectively engaged with the receptacle 24 such that the engagement is permanent or only when desired by the patient. Alternatively, the column 14 may be selectively directly engaged with a tube 28 carrying therapeutic gas therethrough.

As shown in FIG. 2, the inlet 22 may include a swivel joint 36 to allow rotational movement of the inlet 22 about the mask assembly 20. The inlet 22 may be a hose 40 for providing flow communication of the process gas from a fluid source 41 to the inlet 22.

The container 24 can include a tube 28, the tube 28 being configured for flexible movement to position the nasal assembly 12 over the nose of various patients of various sizes. The mask assembly 20 can be configured for sealing engagement with the patient's mouth via an adhesive pad 42 that is selectively engageable with the mask body 46 and carried by the mask body 46. A chamber 58 may be defined within the mask body 46 through which therapeutic gas enters from the inlet 22. In this manner, in one operating state, the mask assembly 20 may sealingly engage the oral region of the patient, while the nasal assembly 12 may also engage the nostrils or nasal region of the patient. In this operating state, the therapeutic gas can be supplied to both the oral and nasal regions of the patient. The mask body 46 may further define a sleeve recess 38 for mating with a fitting as further described herein.

Alternatively, the face plate 44 may be provided for sealing engagement with the mask assembly 20 to seal the chamber 58 so that the therapeutic gas does not enter the area around the patient's mouth, but rather passes only through the nasal assembly 12. In this manner, one or more of the devices 10 disclosed herein may be suitably configured for CPAP applications in which the patient receives therapeutic gas to both their mouth and nose, as well as CPAP applications in which the patient receives therapeutic gas only to their nose. Additionally, if the patient does not wish to use the nasal engagement configurations provided herein, one or more plugs 48 may be provided for use with the mask assembly 20 to seal the container 24. Accordingly, the respiratory assembly 10 described herein may have three different modes of operation: one of the therapeutic gases is provided only to the patient's mouth, one of the therapeutic gases is provided only to the patient's nose, and one of the therapeutic gases is being provided to the patient's nose and mouth.

In one or more embodiments, the inlet 22 may further include a ball and socket joint 50 as shown in FIG. 2, the ball being designated 50 and the socket recess being designated 38. The ball and socket joint allows rotational movement of the inlet 22. The ball 50 may define a plurality of vents 52 to allow therapeutic gas to flow therethrough. The size and position of the vent 52 may be adjusted so that the manipulation of all exhaled fluid (e.g., carbon dioxide) from the patient is controlled and titratable so that the flow rate of the fluid may be changed to a desired setting. In an alternative embodiment, as shown in fig. 3 and 4, each tube 28 of a pair of tubes 28, each column 14 of a pair of columns 14, or both, may include a vent or vent 52 for allowing the passage of gas. In addition, vent 52 may be regulated for titrating the gas passing therethrough. In some embodiments, the vents 52 may be comprised of polymeric fibers, films, or meshes having extremely small thicknesses ranging from nano-scale to micro-scale. The polymer fibers may be made by electrospinning PTFE (polytetrafluoroethylene).

In one or more embodiments, the mask body 46 can include an adjustable mechanism that allows the conduit from the column 14 to be changed, moved, or raised to accommodate the patient's facial structures, primarily the distance between the nose and the oral shell ports on or in the body 46, allowing for a desired facial angle and facial length, which can increase patient comfort. To further increase the comfort, usability, and effectiveness of the respiratory assembly 10, nasal assembly 12, and/or mask assembly 20, software and printing capabilities can be used to customize the shape and contours of the various respiratory assembly 10 and/or nasal assembly 12. For example, but not limiting of, the nose-engaging portion 16 of the nasal assembly 12 may be specifically shaped to fit each nasal passage of the patient 1. Such customization may be accomplished by digitally scanning features of the patient's face to create a CAD model or 3D printing. In addition, various portions or the entirety of the mask body 46 and/or the adhesive pad 42 can be customized to more effectively fit the facial contours of the patient 1. Such customization may be applied to any component of the respiratory assembly 10, including, but not limited to, the nasal assembly 12, the base 90, the connector 91, the sleeve 94, the splint assembly 80, the sheet 30, and/or the shunt 60.

FIG. 3 illustrates a nasal assembly 12 mounted on a patient 1 in accordance with at least one embodiment. The nasal assembly 12 may include a pair of tubes 28, each tube 28 being in gaseous communication with a hose 40 or a fluid source 41. The pair of tubes 28 and the hose 40 may be integrally formed. Optionally, a flow diverter 60 may be positioned between each of the pair of tubes 28 and the hose 40 or the fluid source 41. The flow diverter 60 may be engaged with each of the pair of tubes 28 and the hose 40 or the fluid source 41 to allow gas communication between each of the pair of tubes 28 and the hose 40 or the fluid source 41. The diverter 60, the pair of tubes 28 and the hose 40 may be integrally formed.

Engagement of the diverter 60 with the tube 28 and/or the hose 40 or the fluid source 41 can be accomplished using a variety of different structural configurations. Some structural configurations may allow greater pivotal movement between the

elements

28, 40, 60 while maintaining a sealable engagement to prevent gas leakage therefrom. The diverter 60 may have two tube engaging ends 62 for engaging the tube 28 and one source engaging end 64 for engaging the hose 40 or the fluid source 41. Tube 28 may include a tube diverter receiver 66. The hose 40 or the fluid source 41 may include a source diverter receiver 68. In some embodiments, the

receptacles

66, 68 or engagement ends 62, 64 may be circumferentially extending structures that engage with corresponding recessed structures. Alternatively, the

receivers

66, 68 or engaging ends 62, 64 may be diverter or tube sockets that engage respective tube or diverter ball joints to allow pivotal movement of the tube 28 about the diverter 60.

In at least one embodiment, such as the embodiment depicted in FIG. 4. Each post 14 of the nasal assembly 12 may include an extension 34 for selectively engaging a corresponding receiving portion 35 of the pair of tubes 28. The engagement of the column 14 with the container 24 or tube 28 may use a number of different structural configurations. The extension portion 34 may be a circumferentially extending portion for selectively engaging a corresponding recessed receiving portion 35. Alternatively, the extension portion 34 may be a cylinder ball joint and the receiving portion 35 is a socket, and wherein the cylinder ball joint 34 and the socket 35 are configured for selective engagement to allow pivotal movement of the pair of tubes 28 about each of the pair of cylinders 14, as shown in fig. 4. Another alternative embodiment may include the extension 34 being a rear socket and the receiving portion 35 being a tube ball joint, wherein the rear socket 34 and the tube ball joint 35 are configured to selectively engage to allow pivotal movement of the pair of tubes 28 about each of the pair of posts 14.

According to some embodiments, the nasal assembly 12 includes a pair of posts 14. Fig. 5A and 5B illustrate the nasal assembly 12 in greater detail according to at least one embodiment. The post 14 may include a flange 26, the flange 26 being configured for engagement with a sheet 30 having an adhesive 32 applied thereon, or alternatively, a layer of the adhesive 32 or a layer of the adhesive including the sheet 30 for adhering and providing a sealing engagement with the nares of the patient 1. The sheet 30 may have any desired shape and may preferably include openings therein to allow flow through the openings 29 defined in the cylinder 14. The adhesive 32 may be a pressure sensitive adhesive such that the sheet 30 may be adhered and removed from the patient's nostrils as desired. The post 16 may include an extension 34 on a second end thereof, the extension 34 configured for selective engagement with at least one receptacle 24 of a pair of tubes 28 or a respective tube 28.

The adhesive 32 (and/or the sheet 30) may have different thicknesses, adhesive strengths, and flexibilities. The thickness, bond strength, and flexibility may be different between each adhesive 32 and/or may vary within each individual adhesive 32 itself. For example, the flexibility of the adhesive 32 may be more rigid with the nostril engaging portions and more flexible elsewhere. The adhesive 32 may be comprised of foamed medical tape, surgical tape, and/or hypoallergenic tape. The adhesive 32 may include a hydrocolloid band 18 and/or may include a polyurethane reactive layer that is more secure to the nostrils when the patient's body temperature warms the adhesive 32. Adhesive 32 may comprise a polyvinyl chloride or polyolefin foam tape and/or an acrylate adhesive layer. In some embodiments, the adhesive 32 may comprise a cloth layer adhered to the cylinder 14 using an adhesive substance or tape.

In some embodiments, each column 14 of the pair of columns 14 may include a flange 26 defining an opening 29 therein, the opening 29 being in gaseous communication with each corresponding tube 28 of the pair of tubes 28. Additionally, adhesive 32 or a layer of adhesive 32 may be applied to each post 14, each post 14 configured to sealingly engage a nostril of a patient. The adhesive 32 may be applied to the sheet 30 on the nose-facing side of the post 14, or the adhesive may be applied directly to the flange 26 of the post 14. The adhesive 32 may be a pressure sensitive material.

Fig. 6 illustrates a perspective view of the respiratory assembly 10, the respiratory assembly 10 having a base 90 and a single connector 91, in accordance with one or more embodiments disclosed herein. It is noteworthy that 6, 8 and 11 are both strapless and facemask-a significant advantage over the prior art, where straps and facemasks often left marks on the patient's body. The base 90 may include any number of vents 52. For example, as shown in fig. 9, the vent 52 may be positioned on the bottom side of the base 90. The base 90 may also include or define a base pipe engagement 103 for selectively engaging or connecting to the hose 40 or fluid source 41. The base pipe joint 103 and the hose 40 or fluid source 41 may allow the two to fully rotate relative to each other. The base portion 90 and the base pipe joint 103 may be integrally or separately formed. The base pipe joint 103 may relate to any joint described herein, including but not limited to a ball joint, snap joint, clamp joint, cleat joint, or other form of joint. The base pipe joint 103 may include vents 52 or may include a textured or contoured surface to facilitate maneuverability and operation of the respiratory assembly 10.

The vent 52 of the present invention may be located proximal to any area where fluid flow occurs. For example, but not limiting of, the vent 52 may be placed on the base 90, the connector 91, the column 14, the sleeve 94, the base pipe joint 103, and the like. The vent 52 may be manufactured using a 3D thermoplastic printing process. The vent 52 may be comprised of micro-holes. Micropores can be created using a matrix of very thin fibrils. The fibrils may be composed of Polytetrafluoroethylene (PTFE).

The base 90 and the single connector 91 may be constructed integrally or separately. For example, the base 90 may be constructed of a hard plastic and the connector 91 may be constructed of silicone. The base 90, socket 94, strut 14 and/or other components of the respiratory assembly 10 may be constructed of a plastic, such as, but not limited to, polypropylene or polyethylene, which may be of food or medical grade quality. The possibilities of construction in whole or in isolation and including plastic and silicone may additionally be applied in embodiments such as those depicted in fig. 8 and 11 and other embodiments described herein. The connector 91 of fig. 6 includes a connector body 92 and two connector arms 93. The connector arms 93 may each selectively engage or connect with a sleeve 94. The sleeve 94 may engage or connect the inner portion of the connector arm 93 (see fig. 6), the outer portion of the connector arm 93, or both the inner and outer portions. In one embodiment, the sleeve 94 may engage the connector arm 93 (and/or the post 14 may engage the sleeve 94) by sliding into a groove of the connector arm 93 (and/or the sleeve 94).

The base 90 may be configured to receive a flow of liquid from the hose 40 or the fluid source 41. The base 90 may further define at least one base opening 96. Fig. 6 depicts an embodiment in which the base includes a single base opening 96 for selectively engaging or connecting to the connector 91. In other embodiments, as shown in fig. 8 and 11, for example, the base may include more than one base opening 96, two in fig. 8 and four in fig. 11. Any number of base openings 96 may be included to provide various configurations suitable for the contours of various patients 1. Further, the engagement or connection of the one or more base openings 96 and the one or more connectors 91 may use the conventions described herein.

Fig. 7 illustrates a rear view of the respiratory assembly 10 having a base 90 and two connectors 91 in accordance with one or more embodiments disclosed herein. The base 90 may define a base recess 97 for allowing the patient's lips to move more freely or enter therein by being shaped away from the patient's face when the respiratory assembly 10 is engaged with the patient's nares. In addition, the base 90 may include one or more base protrusions 98 and base ramps 99 for minimizing the volume in which the respiratory assembly 10 is being used, thereby allowing greater access to the patient's face and easier manipulation of the various components of the respiratory assembly 10.

The base 90 of fig. 7 defines two base openings 96 for selectively engaging or coupling to each of the at least two connectors 91. More than two connectors 91 may be provided such that the connectors 91 may be interchanged as desired to change the shape (and thus the airflow), angle (and thus the position), and/or type, which may include any of the engagements described herein. Each connector 91 may be shaped and constructed of a material for deformability such that the connector arms 93 may flex relative to the connector body 92. A sleeve 94 may be included in the respiratory assembly 94 to selectively engage or couple to the connector 91.

Fig. 8 illustrates a perspective view of a base 90 of a respiratory assembly 10 having two base openings 96 and a base tube interface 103, according to one or more embodiments disclosed herein. Fig. 9 illustrates a bottom view of the base 90 of the respiratory assembly 10 having two base openings 96 in accordance with one or more embodiments disclosed herein. Fig. 10 illustrates a rear view of a base 90 of the respiratory assembly 10 having two base openings 96 in accordance with one or more embodiments disclosed herein.

Fig. 11 illustrates a rear view of the base 90 of the respiratory assembly 10, the respiratory assembly 10 having four base openings 96 and two caps 102, according to one or more embodiments disclosed herein. The two caps 102 may cover the base opening 96 when not in use and/or when the base opening 96 is not engaged or connected to the connector 91. The base openings 96 may be of similar size and shape so that the connectors 91 may be interchanged and repositioned to be freely located in each opening 96. Such customization allows the patient to selectively engage or couple the connector 91 to any two openings 96 to best fit the patient's nares. By allowing for splint engagement or ball and joint engagement or any other engagement to allow for multiple positioning, and/or by providing an angled post 14 and/or connector 91, the connector 91, connector arm 93 and/or post 14 may be positioned to best fit the patient's nares when the respiratory assembly 10 is engaged.

Fig. 12 illustrates a cleat assembly 80 and a rotatable sleeve assembly 94 in accordance with one or more embodiments disclosed herein. The sheet 30 of the respiratory assembly 10 may be embedded into a splint assembly 80, wherein the splint assembly 80 defines a splint flange 82 extending between the layers of the sheet 30. Alternatively, the sheet 30 and/or adhesive 32 may be applied to the nose-facing side of the cleat flange 82 of the cleat assembly 80, similar to the nose-engaging portion 16 of the post 14 described herein. The sheet 30, nose engaging portion 16 and/or splint flange 82 may be formed to create a variety of shapes to fit a wide variety of nostrils 4 and nostrils 3 of a patient. For example, in FIG. 6, the sheet 30 is substantially circular similar to the nose 4 and extends outwardly in a triangular fashion on one side and has a curved apex; such an embodiment provides a larger surface area for adhering to the patient 1. As shown in fig. 5, the sheet 30 is substantially circular. Throughout the description, the cleat flange 82 and the nose engaging portion 16 may be used interchangeably. In other embodiments, the sheet 30, the nose engaging portion 16, and/or the cleat flange 82 may be radially undulating, concave, or convex to conform to the nostrils in a conforming manner. The sheet 30 and/or splint flange 82 may overlap between the nostrils 4 when applied to the patient 1 to provide additional support and adhesion. The cleat flange 82 may be similarly shaped and arranged.

The cleat flanges 82 of the cleat assembly 80 may be rigid to provide support or flexible to conform to the shape of the patient's nostrils 4 and 3. The splint assembly 80 may further define a splint extension 84 extending from the center or interior of the splint flange 82 and away from the patient 1. The splint extension 84 may be substantially cylindrical or may be selectively shaped for engaging the post 14 or sleeve 94 of the nasal assembly 12. Cleat extension 84 may define a plurality of cleat ridges 86 on the inside of cleat extension 84-cleat opening 85-and/or on the outside of cleat extension 84. The cleat ridges 86 may each define a distal end 87 defined by the cleat ridge 86 that is further from the cleat flange 82 than a proximal end 88. The distal end 87 and proximal end 88 can be arranged to allow clockwise or counterclockwise rotation of the post 14 or sleeve 94 relative to the cleat assembly 80. Additionally, the cleat ridge 86 may define a tapered edge 89 on the distal end 87 and/or the proximal end 88 to facilitate smooth rotation and locking of the cleat assembly 80 and the post 14 or sleeve 94.

In an alternative embodiment, the cleat ridge 86 and the post or sleeve ridge 110 may be L-shaped, and the cleat assembly may also be a spring-based ring (not shown) on the cleat flange 82. During engagement of the post 14 or sleeve 94 cleat assembly 80, the ridges may be pushed past each other and the post 14 or sleeve 94 may be twisted, then, upon release by the patient, the spring ring will lock the cleat assembly 80, post 14 or sleeve 94 in place. The sleeve spine 110 may define proximal and distal sleeve ends 112, 114 similar to the proximal and distal ends 87,88 of the cleat spine 86.

Although a sleeve 94 is depicted in fig. 12, the post 14 may similarly be selectively engaged with the cleat assembly 80. The sleeve 94 or post 14 may include a position identifier (AH) for allowing the patient to selectively engage the sleeve 94 or post 14 to a particular desired position by aligning the desired position identifier (AH) with the splint position identifier 104. The sleeve 94 or post 14 may further define a gripping feature 105 for easily rotating the sleeve wrench head 106. The sleeve wrench head 106 may freely rotate about the sleeve base 107. In other embodiments (fig. 13A-D), sleeve base 107 may be shaped to engage with connector 91 and/or connector arm 93. Additionally, the sleeve 94 or post 14 may include a deformable O-ring 108 that, when engaged, sealingly engages or connects the sleeve 94 or post 14 to the cleat assembly 80. In one embodiment, with sleeve 94 engaged or connected to the exterior of connector arm 93, connector arm 93 may extend within sleeve 94 and define an O-ring 108 for sealing sleeve-cylinder 94-14 engagement or coupling.

Fig. 13A-D illustrate a sleeve assembly 94 and a cylinder 14 according to one or more embodiments disclosed herein. The post 14 may include a nose engaging portion 16, the nose engaging portion 16 being angled relative to a post body 17 for enhancing positioning of the nose engaging portion 16 relative to the nares. The angle may be 15 degrees or any angle between 0 and 45 degrees. This angle may be created by having a portion of the post body 17 bulge outwardly at an angle, as shown in fig. 13B and 13C. The intersection of the protrusion 17A and the post body 17 or the entire protrusion 17A itself may be flexible or deformable and may be constructed of a different material than the rest of the post body 17. Alternatively, the post body 17 may remain substantially cylindrical with a top that is "cut" at an angle.

The sleeve assembly 94 may include one or more grippers 117 for engaging and disengaging the sleeve 94 from the column 14. The gripper 117 may extend at an angle from the collar end 119 of the sleeve distal from the connector 91 for providing leverage to the gripper 117 when "gripped," thereby enabling the collar 119 of the sleeve to be deformed away from the cylinder 14 for release. The sleeve cavity 118 may be defined by the sleeve 94 to allow the sleeve 94 to deform when clamped. For example, as shown in fig. 13D, the sleeve cavity 118 extends through the flange portion 118 of the sleeve 94 and is located horizontally below the flange portion 118 to allow the left or right halves of the flange 118 to deform when the gripper 117 is gripped. Squeezing involves applying pressure on one or more of the grippers 117, either individually or simultaneously, such that the grippers 117 flex toward the sleeve 94, thereby lifting the flange bead 130 of the flange 119 and releasing the barb 132 of the column 14.

14A-14D illustrate a sleeve assembly 94 having a clamp lock 120 in accordance with one or more embodiments disclosed herein. The clip lock 120 may include two clip extensions 121. The first clamp extension 121A may define a first clamp abutment 122A and the second clamp extension 121B may define a second clamp abutment 122B. One or both clamp abutments 122 can include a clamp ridge 123 for allowing the clamp abutments 122 to lockingly engage when the extensions 121 are clamped together. Once engaged, clamp abutments 122 can then be clamped apart. In one embodiment, clamping the extensions 121 together engages the flange bead 130 with the cylinder 14 to secure the cylinder 14 in place. The post 14 may define a locator 132 (on the underside of the post, a small projection away from the nose engaging portion 16) for further fixing the position of the post 14 and resisting rotation of the post 14 when the locator 132 engages a locating hole 134 defined by the sleeve 94.

In some embodiments, the respiratory assembly 10, nasal assembly 12, mask assembly 20, and/or any of the components thereof, may further include an oral device engagement member 70 for engaging the oral device 9 engaged with the patient's mouth. For example, but not limiting of, the patient may have a mouth guard, a mandibular forward splint, or some other oral device 9 that may be used in conjunction with the respiratory assembly 10, nasal assembly 12, and/or mask assembly 20. The oral device engagement member 70 can selectively engage the respiratory assembly 10, nasal assembly 12, and/or mask 10 to the oral device 9 for stabilizing the position of the respiratory assembly 10, nasal assembly 12, and/or mask 10 relative to the patient 1.

In one or more embodiments, the respiratory assembly 10, or any of its components, may be provided as a short-term use product, such that the entire system is discarded and replaced after a predetermined period of use. For example, the respiratory assembly 10 may be configured for use as a three month use product, such that the patient receives a new respiratory assembly 10 every three months. In one embodiment, the post 14, anti-staple assembly 80 may be a disposable product. The patient may install a new adhesive pad 42 and sheet 30 after each use.

While the embodiments have been described in connection with the preferred embodiments of the various figures, it is to be understood that other similar embodiments may be used or modifications and additions may be made to the described embodiments for performing the same function without deviating therefrom. Therefore, the disclosed embodiments should not be limited to any single embodiment, but rather construed in breadth and scope in accordance with the appended claims.

Claims

1. A respiratory assembly, comprising:

a base engaged with the at least one connector and in fluid communication with a hose or fluid source to allow gas communication between the at least one connector, the base, and the hose or fluid source;

a pair of sleeves separable from the at least one connector, wherein each sleeve is selectively engageable with the at least one connector, each sleeve being independently movable relative to the other sleeve;

a pair of posts, each post selectively engageable with at least one of the pair of sleeves, wherein each post comprises:

a flange defining an opening therethrough in fluid communication with each corresponding sleeve of the pair of sleeves, the flange being defined at an end of each post such that when the flange is engaged with the patient's nares, each post does not extend into the patient's respective nares;

an adhesive adhered to each flange and configured to sealingly engage the patient's nares;

the respiratory assembly is facemask-less and strapless such that when the respiratory assembly is worn by a patient, fluid from the hose or fluid source will flow through the at least one connector into the patient's nares, rather than into the patient's mouth.

2. The respiratory assembly of claim 1, wherein the adhesive is a pressure sensitive material.

3. The respiratory assembly of claim 1, wherein the adhesive comprises a foam.

4. The respiratory assembly of claim 1, wherein the base defines two openings for engaging two connectors.

5. The respiratory assembly of claim 1, wherein the base defines four openings for engaging two connectors and two caps.

6. The respiratory assembly of claim 1, wherein the flange of the post is angled relative to a post body defined by the post, each post body selectively engaging at least one of the pair of sleeves.

7. The respiratory assembly of claim 4 or 5, wherein the connector defines a concave surface located at least between two openings.

8. The respiratory assembly of claim 1, further comprising a vent for titrating fluid.

9. The respiratory assembly of claim 1, wherein each of a pair of sleeves includes a clamp that allows selective engagement between the sleeve and post.

10. The respiratory assembly of claim 1, wherein each of a pair of sleeves includes a clip assembly to allow selective engagement between the sleeve and post, wherein the clip assembly defines two clip extensions that can be selectively engaged using at least one clip ridge.

11. The respiratory assembly of claim 9 or 10, wherein the selective engagement includes engaging barbs of the post with flanges of the sleeve.

12. The breathing assembly includes:

a pair of cleat assemblies, each cleat assembly selectively engaged with at least one of the pair of sleeves, wherein each cleat assembly comprises:

a splint flange engaged with the sheet comprising adhesive for engaging the patient's nostrils, wherein the splint flange is defined at an end of each splint assembly such that when the splint assembly is engaged with the patient's nostrils, each splint assembly does not extend into the patient's respective nostril;

a clamp plate opening in gaseous communication with each corresponding sleeve of the pair of sleeves;

at least one wedge ridge for selectively engaging at least one sleeve ridge of one of the pair of sleeves;

13. The respiratory assembly of claim 12, wherein the adhesive is a pressure sensitive material or comprises a foam.

14. The respiratory assembly of claim 12, wherein the base defines two openings for engaging two connectors.

15. The respiratory assembly of claim 12, wherein the base defines four openings for engaging two connectors and two caps.

16. The respiratory assembly of claim 12, wherein the cleat flange is angled relative to the sleeve when the cleat assembly and the sleeve are engaged.

17. The respiratory assembly of claim 14 or 15, wherein the connector defines a concave surface at least between two openings for providing access to a patient.

18. The respiratory assembly of claim 1, further comprising a vent for titrating fluid.

19. A respiratory component comprising

A base engaged with the at least one connector, wherein the base is in fluid communication with a hose or fluid source to allow gas communication between the at least one connector, the base, and the hose or fluid source;

a pair of sleeves engaged with the at least one connector, wherein each sleeve defines: a collar; a cavity extending through the collar for receiving a corresponding post; a pair of grippers allowing selective engagement between the sleeve and cylinder;

wherein the collar has a first mode of operation in which a post is engaged with the collar and a second mode of operation in which the post is not engaged with the collar in response to pressure applied by a user to one or more grippers extending from each pair of sleeve ends, wherein the applied pressure causes distal ends of the one or more grippers to flex toward each of the pair of sleeves, lifting a flange of the collar and releasing a barb of the post, thereby releasing the post and the collar, wherein the post is configured to sealingly engage a nostril of a patient.

20. The respiratory assembly of claim 19, wherein the posts sealingly engage the patient's nares through the use of a pressure sensitive adhesive.

21. The respiratory assembly of claim 20, wherein the adhesive comprises a foam.

22. The respiratory assembly of claim 19, wherein the respiratory assembly is facemask-less and strapless.

23. The respiratory assembly of claim 19, wherein the base defines two openings for engaging two connectors.

24. The respiratory assembly of claim 19, wherein the base defines four openings for engaging two connectors and two caps.

25. The respiratory assembly of claim 19, wherein each post includes a flange angled relative to a post body defined by the post, each post body selectively engaging at least one of the pair of sleeves.

26. The respiratory assembly of claim 23 or 24, wherein the connector defines a concave surface located at least between two openings.

27. The respiratory assembly of claim 19, further comprising a vent for titrating fluid.

28. The respiratory assembly of claim 19, wherein the selective engagement includes engagement of a barb of the post with a flanged bead of the sleeve.

29. The respiratory assembly of claim 27, wherein the vent is adjustable.

30. The respiratory assembly of claim 27, wherein the vent is located on the base, connector, post, or sleeve.

31. The respiratory assembly of claim 27, wherein the vent comprises micro-pores.